Amgen · 19 hours ago
Product Quality Director - Synthetics
Thousand Oaks, CA
Full-time
Onsite
Director/Executive
7+ years expAmgen is a biotechnology company committed to serving patients with serious illnesses. The Product Quality Director - Synthetics will lead the Product Quality organization, providing technical expertise and strategic leadership to ensure product quality throughout the product development lifecycle.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Provide effective, cross-functional quality leadership, and manage multiple, complex long-term PDT deliverables for late phase and commercial programs, including actions required for the PQT/APR; specification, comparability, and stability programs; site and method transfers; product quality impact statements for NCs; and PQ owned regulatory filing sections and RTQs
Provide expertise in science and risk-based evaluation of complex processes and product quality data, including ability to develop patient-oriented strategies that account for business needs and/or provide novel solutions to complex issues
Demonstrate proficiency in oral and written communication of complex information to Amgen leadership, peers and regulatory agencies including communications associated with inspectional activities
Demonstrate proficiency in knowledge of cGMP and international regulatory expectations
Understand and respond to the impact of emerging scientific/technical trends and their implications for Amgen
Actively mentor new and existing team members to develop Product Quality core skills
Qualification
Required
Bachelor's Degree and 9 years of Quality, Operations, Scientific, or Manufacturing experience OR
Master's Degree and 7 years of Quality, Operations, Scientific, or Manufacturing experience OR
Doctorate Degree and 4 years of Quality, Operations, Scientific, or Manufacturing experience
Preferred
Advanced degree in chemistry, biochemistry, biology, or a related biotechnology sciences field
Expertise in the areas of drug substance and drug product manufacturing, analytical testing, and industry regulations related to small molecules, peptides and/or oligonucleotides
8+ years of pharmaceutical experience with increasing responsibility in quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment experience
6+ years working in a regulated environment (direct GMP)
4 years experience managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
2+ years experience as a technical expert or product champion
1+ years of experience with authoring or review of regulatory filing or similar regulatory documentation
1+ years of experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
Experience in Project Management in support of product development
Knowledge of quality, compliance and regulatory requirements
Knowledge of analytical techniques used for synthetic product quality control
Understanding of drug substance and drug product development and manufacturing
Strong leadership and management skills
General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture and testing of pharmaceuticals
Previous experience working on a cross-functional team in a matrix environment
Excellent written and verbal communication skills, including facilitation and presentation skills
Benefits
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible.
Company
Amgen
Amgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases.
10001+ employees
H1B Sponsorship
Amgen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (429)
2024 (485)
2023 (485)
2022 (540)
2021 (460)
2020 (444)
Funding
Current Stage
Public CompanyTotal Funding
$28.5B2022-12-12Post Ipo Debt· $28.5B
1983-06-17IPO
Leadership Team
Robert Bradway
Chairman and Chief Executive Officer
Jay Bradner
Executive Vice President of R&D, and Chief Scientific Officer
Recent News
2026-01-08
FierceBiotech
2026-01-08
pharmaphorum
2026-01-08
Company data provided by crunchbase